Implantable medical lead for stimulation of multiple nerves

ABSTRACT

In various examples, an apparatus includes a stimulation lead including an elongate body including a distal end and a proximal end. At least one first electrode is disposed proximate the distal end of the elongate body and is configured to stimulate a first target nerve. At least one second electrode is disposed between the at least one first electrode and the proximal end of the elongate body and is configured to stimulate a second target nerve. At least one first fixation structure is disposed between the at least one second electrode and the proximal end of the elongate body. The at least one first fixation structure is configured to anchor the stimulation lead proximate the sacrum, wherein the at least one first fixation structure is located on the elongate body and spaced a first distance proximally along the elongate body from the at least one first electrode.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. Utility application Ser. No.14/535,386, filed Nov. 7, 2014, entitled “IMPLANTABLE MEDICAL LEAD FORSTIMULATION OF MULTIPLE NERVES” which claims the benefit of priority toU.S. Provisional Application Ser. No. 61/901,499, filed on Nov. 8, 2013,entitled “STIMULATION APPARATUSES, DEVICES, SYSTEMS, AND METHODS,” andU.S. Provisional Application Ser. No. 61/923,927, filed on Jan. 6, 2014,entitled “STIMULATION APPARATUSES, DEVICES, SYSTEMS, AND METHODS,” eachof which is incorporated by reference herein in its entirety.

TECHNICAL FIELD

The present patent document pertains generally to a stimulationapparatus, system, and method and more particularly, but not by way oflimitation, to an implantable apparatus, system, and method forstimulation of multiple nerves.

BACKGROUND

Stimulation of various nerves and tissue has been found to be apromising treatment for various conditions and/or ailments. Forinstance, pain, urinary urge, fecal incontinence, and epilepsy, to namea few, are indications for various nerve/tissue stimulation therapies.Various nerves and tissue are commonly targeted for stimulation therapy,including, but not limited to the sacral nerve, the pudendal nerve, thevagus nerve, the tibial nerve, and the spinal cord, to name a few.

Access to the pudendal nerve can be achieved in various ways, includinga transgluteal approach, an ischiorectal fossa approach, atransobturator approach, and a transforaminal approach. The pudendalnerve arises from sacral nerve roots S2, S3, and S4. In some examples,such as, for instance, the transforaminal approach, the pudendal nervecan be accessed by following one of the sacral nerve roots S2, S3, andS4 to the pudendal nerve.

Overview

This overview is intended to provide an overview of subject matter ofthe present patent document. It is not intended to provide an exclusiveor exhaustive explanation of the invention. The detailed description isincluded to provide further information about the present patentdocument.

The present inventors have recognized, among other things, that thesubject matter can be used to stimulate one or more nerves or othertissue. The present inventors have further recognized, among otherthings, that the subject matter can be used with an implantablestimulation system. To better illustrate the apparatuses, systems, andmethods described herein, a non-limiting list of examples is providedhere:

Example 1 can include subject matter that can include a stimulation leadincluding an elongate body including a distal end and a proximal end. Atleast one first electrode is disposed proximate the distal end of theelongate body. The at least one first electrode is configured tostimulate a first target nerve. At least one second electrode isdisposed between the at least one first electrode and the proximal endof the elongate body. The at least one second electrode is configured tostimulate a second target nerve. At least one first fixation structureis disposed between the at least one second electrode and the proximalend of the elongate body. The at least one first fixation structure isconfigured to anchor the stimulation lead proximate the sacrum, whereinthe at least one first fixation structure is located on the elongatebody and spaced a first distance proximally along the elongate body fromthe at least one first electrode.

In Example 2, the subject matter of Example 1 is optionally configuredsuch that the at least one first electrode includes a plurality of firstelectrodes, and the at least one second electrode includes a pluralityof second electrodes.

In Example 3, the subject matter of any one of Examples 1-2 isoptionally configured such that the elongate body includes a firstportion and a second portion, wherein the second portion is coaxiallydisposed around the first portion. The at least one first electrode isdisposed on the first portion of the elongate body.

In Example 4, the subject matter of Example 3 is optionally configuredsuch that the at least one second electrode is disposed on the secondportion of the elongate body.

In Example 5, the subject matter of Example 4 is optionally configuredsuch that an electrode distance between the at least one first electrodeand the at least one second electrode is adjustable with movement of thesecond portion of the elongate body with respect to the first portion ofthe elongate body.

In Example 6, the subject matter of any one of Examples 1-5 optionallyincludes at least one second fixation structure disposed on the elongatebody distally from the at least one first fixation structure.

In Example 7, the subject matter of Example 6 is optionally configuredsuch that the at least one second fixation structure is located on theelongate body proximate the at least one first electrode.

In Example 8, the subject matter of any one of Examples 1-7 isoptionally configured such that the first distance is 5-10 cm.

In Example 9, the subject matter of any one of Examples 1-8 optionallyincludes a sheath removably disposed around at least the at least onefirst fixation structure, wherein the at least one first fixationstructure includes a delivery configuration with the sheath disposedaround the at least one first fixation structure to constrain the atleast one first fixation structure. The at least one first fixationstructure includes a deployed configuration with the sheath removed fromaround the at least one first fixation structure to allow the at leastone first fixation structure to extend outwardly from the elongate body.

In Example 10, the subject matter of any one of Examples 1-9 isoptionally configured such that the at least one first fixationstructure includes at least one fin.

Example 11 can include, or can optionally be combined with any one ofExamples 1-10 to include subject matter that can include a stimulationlead including an elongate body including a distal end and a proximalend, wherein the elongate body includes a first portion and a secondportion. The second portion is coaxially disposed around the firstportion. At least one first electrode is disposed on the first portionof the elongate body proximate the distal end of the elongate body. Theat least one first electrode is configured to stimulate a first targetnerve. At least one second electrode is disposed on the second portionof the elongate body between the at least one first electrode and theproximal end of the elongate body. The at least one second electrode isconfigured to stimulate a second target nerve, wherein an electrodedistance between the at least one first electrode and the at least onesecond electrode is adjustable with movement of the second portion ofthe elongate body with respect to the first portion of the elongatebody.

In Example 12, the subject matter of Example 12 is optionally configuredsuch that the at least one first electrode includes a plurality of firstelectrodes, and the at least one second electrode includes a pluralityof second electrodes.

In Example 13, the subject matter of any one of Examples 11-12optionally includes at least one first fixation structure disposedbetween the at least one second electrode and the proximal end of theelongate body. The at least one first fixation structure is configuredto anchor the stimulation lead proximate the sacrum, wherein the atleast one first fixation structure is located on the elongate body andspaced a first distance proximally along the elongate body from the atleast one first electrode.

In Example 14, the subject matter of Example 13 optionally includes atleast one second fixation structure disposed on the elongate bodydistally from the at least one first fixation structure.

In Example 15, the subject matter of Example 14 is optionally configuredsuch that the at least one second fixation structure is located on theelongate body proximate the at least one first electrode.

In Example 16, the subject matter of any one of Examples 13-15optionally includes a sheath removably disposed around at least the atleast one first fixation structure, wherein the at least one firstfixation structure includes a delivery configuration with the sheathdisposed around the at least one first fixation structure to constrainthe at least one first fixation structure. The at least one firstfixation structure includes a deployed configuration with the sheathremoved from around the at least one first fixation structure to allowthe at least one first fixation structure to extend outwardly from theelongate body.

In Example 17, the subject matter of any one of Examples 13-16 isoptionally configured such that the at least one first fixationstructure includes at least one fin.

Example 18 can include, or can optionally be combined with any one ofExamples 1-17 to include subject matter that can include a stimulationlead including an elongate body including a distal end and a proximalend, wherein the elongate body includes a first portion and a secondportion. The second portion is coaxially disposed around the firstportion. At least two first electrodes are disposed on the first portionof the elongate body proximate the distal end of the elongate body. Theat least two first electrodes are configured to stimulate a first targetnerve. At least two second electrodes are disposed on the second portionof the elongate body between the at least two first electrodes and theproximal end of the elongate body. The at least two second electrodesare configured to stimulate a second target nerve, wherein an electrodedistance between the at least two first electrodes and the at least twosecond electrodes is adjustable with movement of the second portion ofthe elongate body with respect to the first portion of the elongatebody. At least one first fixation structure is disposed between the atleast two second electrodes and the proximal end of the elongate body.The at least one first fixation structure is configured to anchor thestimulation lead proximate the sacrum, wherein the at least one firstfixation structure is located on the elongate body and spaced a firstdistance proximally along the elongate body from the at least two firstelectrodes.

In Example 19, the subject matter of Example 18 optionally includes atleast one second fixation structure disposed on the elongate bodydistally from the at least one first fixation structure, wherein the atleast one second fixation structure is located on the elongate bodyproximate the at least two first electrodes.

In Example 20, the subject matter of any one of Examples 18-19optionally includes a sheath removably disposed around at least the atleast one first fixation structure, wherein the at least one firstfixation structure includes a delivery configuration with the sheathdisposed around the at least one first fixation structure to constrainthe at least one first fixation structure. The at least one firstfixation structure includes a deployed configuration with the sheathremoved from around the at least one first fixation structure to allowthe at least one first fixation structure to extend outwardly from theelongate body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a stimulation lead in accordance with at least one exampleof the invention, the stimulation lead being shown partially implantedwithin a patient.

FIG. 2 is an enlarged fragmentary view of the stimulation lead of FIG.1.

FIG. 3 shows a stimulation lead in accordance with at least one exampleof the invention.

FIG. 4 shows a stimulation lead in accordance with at least one exampleof the invention.

FIG. 5A shows a stimulation lead in accordance with at least one exampleof the invention, the stimulation lead including a sheath disposed overfirst fixation structures.

FIG. 5B shows the stimulation lead of FIG. 5A with the sheath retractedto uncover the first fixation structures.

DETAILED DESCRIPTION

This patent document pertains generally to apparatuses, systems, andmethods for body tissue electrical stimulation and more particularly,but not by way of limitation, to apparatuses, systems, and methods fornerve electrical stimulation, including, but not limited to, sacralnerve electrical stimulation, pudendal nerve electrical stimulation,pelvic nerve electrical stimulation, peripheral nerve electricalstimulation, spinal cord electrical stimulation, vagal nerve electricalstimulation, gastric nerve electrical stimulation, and brain nerveelectrical stimulation.

The present inventors have recognized, among other things, that it isdesirable to provide an apparatus, system, and method to stimulate oneor more nerves or other tissue. The present inventors have furtherrecognized, among other things, that the subject matter can be used withan implantable stimulation system. The inventors have recognized that,in some examples, the pudendal nerve can be accessed via the sacralnerve and that a single stimulation device can be used to stimulate oneor both of the pudendal and the sacral nerves. While primarily describedwith respect to stimulation leads and devices, this is merely for thesake of convenience. It should be understood that the subject matterdescribed herein can be used with other implantable medical devices,such as needles, catheters, conductors, tubes, conduits, or the like,for instance, as well as external devices in some examples. Also,although primarily described herein as being used to stimulate apudendal nerve and a sacral nerve, it should be understood that thestimulation leads can be used to stimulate various nerves and/or tissuesand is not limited to stimulating only the pudendal nerve and the sacralnerve.

Referring to FIG. 1, a stimulation lead 100 in accordance with someexamples is shown partially implanted within a patient 10. A sacrum 20of the patient 10 includes foramen 22. Sacral nerves 30 and a pudendalnerve 40 are portrayed below the sacrum 20. The sacral nerves 30 includesacral nerve S1 32, sacral nerve S2 34, sacral nerve S3 36, and sacralnerve S4 38 (herein referred to as S1, S2, S3, and S4 nerves).

Referring still to FIG. 1, using the transforaminal approach to thepudendal nerve 40, in some examples, a physician can “float” orotherwise maneuver the stimulation lead 100 along one of the S2, S3, andS4 nerves 34, 36, 38, for instance, and then continue farther to thenexus where the S2, S3, S4 nerves 34, 36, 38 come together. In someexamples, the S2 nerve 34 may provide a desirable route to the pudendalnerve 40. In further examples, the S3 nerve 36 may provide a desirableroute to the pudendal nerve 40 (as shown in FIG. 1). In still furtherexamples, the S4 nerve 38 may provide a desirable route to the pudendalnerve 40.

In some examples, stimulation of the S3 nerve 36 can be beneficial forvarious treatments, such as, but not limited to urge incontinence,urinary frequency urgency, nonobstructive urinary retention, sexualdysfunction, fecal incontinence, constipation, and interstitialcystitis. In some examples, stimulation of the S2 nerve 34 at this levelis sometimes discouraged because such stimulation can sometimes resultin too much motor activity in the lower extremity. Therefore, in someexamples, where the pudendal nerve 40 is accessed via the S3 nerve 36,one stimulation lead 100 can be used with spaced apart electrodes 110,120. That is, in some examples, one set of proximal electrodes 120 tostimulate the S3 nerve 36 and one set of distal electrodes 110 tostimulate the pudendal nerve 40. However, in other examples, where thepudendal nerve 40 is accessed via the S2 nerve 34, if it is not desiredto stimulate the S2 nerve 34, one lead can be used with distalelectrodes to stimulate the pudendal nerve 40 and another lead can beused to be implanted proximate the S3 nerve 36 to stimulate the S3 nerve36.

Referring again to FIG. 1, the stimulation lead 100, in some examples,includes an elongate body 102 including a distal end 102A and a proximalend 102B. In some examples, at least one first electrode 110 is disposedproximate the distal end 1024 of the elongate body 102. In someexamples, the stimulation lead 100 includes more than one firstelectrode 110, the first electrodes 110 being spaced apart by a spacingdistance. In some examples, the stimulation lead 100 can include aspacing distance between the first electrodes 110 of about 1-3 mm. Insome examples, the first electrodes 110 can be about 1-3 mm in length.In some examples, the stimulation lead 100 includes an array of firstelectrodes 110 proximate the distal end 102A of the elongate body 102.In some examples, the stimulation lead 100 includes a plurality of firstelectrodes 110. In some examples, the stimulation lead 100 includes fourfirst electrodes 110, as shown in the example of FIG. 1. In someexamples, the at least one first electrode 110 is configured tostimulate a first target nerve 40, such as, but not limited to thepudendal nerve 40.

In some examples, at least one second electrode 120 is disposed betweenthe at least one first electrode 110 and the proximal end 1028 of theelongate body 102. In some examples, the stimulation lead 100 includesmore than one second electrode 120, the second electrodes 120 beingspaced apart by a spacing distance. In some examples, the secondelectrodes 120 can be about 1-3 mm in length. In some examples, thestimulation lead 100 can include a spacing distance between the secondelectrodes 120 of about 1-3 mm. In some examples, the stimulation lead100 includes an array of second electrodes 120 disposed between the atleast one first electrode 110 and the proximal end 102B of the elongatebody 102. In some examples, the stimulation lead 100 includes aplurality of second electrodes 120. In some examples, the stimulationlead 100 includes four second electrodes 120, as shown in the example ofFIG. L In some examples, the at least one second electrode 120 isconfigured to stimulate a second target nerve 30, such as, but notlimited to the sacral nerve 30.

In some examples, the stimulation lead 100 includes one to twelveelectrodes 110, 120 in various configurations. For instance, in someexamples, the stimulation lead 100 includes four first electrodes 110located toward the distal end 102A of the stimulation lead 100 forstimulation of the pudendal nerve 40, for instance, and four secondelectrodes 120 spaced proximally from the first electrodes 110 forstimulation of the sacral nerve 30, for instance. In other examples, thestimulation lead 100 includes eight first electrodes 110 located towardthe distal end 102A of the stimulation lead 100 for stimulation of thepudendal nerve 40, for instance, and four second electrodes 120 spacedproximally from the first electrodes 110 for stimulation of the sacralnerve 30, for instance. In some examples, the stimulation lead 100 caninclude six first electrodes 110 and six second electrodes 120. Itshould be understood that the examples described herein are merelyexemplary and that other configurations of electrodes 110, 120 arecontemplated herein. In various examples, any electrode configurationcan be used, depending upon the nerve(s) or tissue(s) to be stimulatedand the approach to be used to get to the nerve(s) and/or tissue(s). Insome examples, programming (for instance, within a pulse generator) canbe used to exclude electrodes 110, 120 that do not properly orsufficiently stimulate the target nerve(s) or tissue(s). For instance,an electrode can be excluded if the stimulation from the electrode hastoo much leg recruitment, pain, or another adverse effect.

Referring now to FIGS. 1 and 2, in some examples, at least one firstfixation structure 130 is disposed on the elongate body 102 for at leastaiding in anchoring the stimulation lead 100 in place within the patient10. In some examples, the at least one fixation structure 130 isdisposed on the elongate body 102 between the at least one secondelectrode 120 and the proximal end 102B of the elongate body 102. Insome examples, the at least one first fixation structure 130 isconfigured to anchor the stimulation lead 100 proximate the sacrum 20.In some examples, the at least one first fixation structure 130 islocated on the elongate body 102 and spaced a first distance proximallyalong the elongate body 102 from the at least one first electrode 110.In some examples, the first distance is configured to allow the at leastone first electrode 110 to be positioned proximate the first targetnerve 40 with the at least one first fixation structure 130 positionedproximate the sacrum 20. In some examples, the first distance is withinthe range of 5-10 cm. In some examples, more than one first fixationstructure 130 is contemplated. For instance, in the example shown inFIGS. 1 and 2, the elongate body 102 includes three sets of three firstfixation structures 130. In some examples, the at least one firstfixation structure 130 includes a fin. In other examples, the at leastone first fixation structure 130 includes other fixation structures,such as tines, barbs, coils, or the like. It is noted that, in variousexamples, different numbers, sizes, and/or types of fixation structurescan be used with the stimulation lead 100, for instance to adjust ortune fixation of the stimulation lead 100 within the patient 10. In someexamples, the at least one first fixation structure 130 provides mainanchoring (major fixation) of the stimulation lead 100.

Referring again to FIG. 1, the stimulation lead 100, in some examples,includes one or more contacts 160 proximate the proximal end 102B of theelongate body 102. The one or more contacts 160, in some examples, areequal in number to the total number of electrodes 110, 120 on thestimulation lead 100. In some examples, the stimulation lead 100includes conductors running between the one or more contacts 160 and thecorresponding one or more electrodes 110, 120. In the example shown inFIG. 1, the stimulation lead 100 includes eight contacts 160,corresponding to the four first electrodes 110 and the four secondelectrodes 120. In other examples, various other numbers and/orconfigurations of connectors 160 are contemplated, depending uponvarious factors, such as, but not limited to, the number of electrodeson the stimulation lead, the device to which the stimulation lead is tobe connected, or the like. The one or more contacts 160, in someexamples, are configured for electrically coupling to one or moreconnectors, for instance, within a pulse generator or other medicaldevice or a lead extension to which the stimulation lead 100 is intendedto be connected. In some examples, the one or more contacts 160 areconfigured to electrically couple the one or more electrodes 110, 120 tothe pulse generator to transmit electrical stimulation pulses generatedby the pulse generator to the appropriate one or more electrodes 110,120 and, in turn, to the appropriate target nerves 30, 40 and/or targettissue.

Referring now to FIG. 3, a stimulation lead 300 in accordance with someexamples is shown for at least partial implantation within a patient.The stimulation lead 300, in some examples, is substantially similar tothe stimulation lead 100 described herein and/or can be used insubstantially similar ways to those described herein with respect to thestimulation lead 100. The stimulation lead. 300, in some examples,includes an elongate body 302 including a distal end 302A and a proximalend 302B.

In some examples, at least one first electrode 310 is disposed proximatethe distal end 302A of the elongate body 302. In some examples, thestimulation lead 300 includes more than one first electrode 310, thefirst electrodes 310 being spaced apart by a spacing distance. In someexamples, the stimulation lead 300 can include a spacing distancebetween the first electrodes 310 of about 1-3 mm. In some examples, thefirst electrodes 310 can be about 1-3 mm in length. In some examples,the stimulation lead 300 includes an array of first electrodes 310proximate the distal end 302A of the elongate body 302. In someexamples, the stimulation lead 300 includes a plurality of firstelectrodes 310. In some examples, the stimulation lead 300 includes fourfirst electrodes 310, as shown in the example of FIG. 3. In someexamples, the at least one first electrode 310 is configured tostimulate a first target nerve, such as, but not limited to the pudendalnerve.

In some examples, at least one second electrode 320 is disposed betweenthe at least one first electrode 310 and the proximal end 302B of theelongate body 302. In some examples, the stimulation lead 300 includesmore than one second electrode 320, the second electrodes 320 beingspaced apart by a spacing distance. In some examples, the secondelectrodes 320 can be about 1-3 mm in length. In some examples, thestimulation lead 300 can include a spacing distance between the secondelectrodes 320 of about 1-3 mm. In some examples, the stimulation lead300 includes an array of second electrodes 320 disposed between the atleast one first electrode 310 and the proximal end 302B of the elongatebody 302. In some examples, the stimulation lead 300 includes aplurality of second electrodes 320. In some examples, the stimulationlead 300 includes four second electrodes 320, as shown in the example ofFIG. 3. In some examples, the at least one second electrode 320 isconfigured to stimulate a second target nerve, such as, but not limitedto the sacral nerve.

In some examples, the stimulation lead 300 includes one to twelveelectrodes 310, 320 in various configurations. For instance, in someexamples, the stimulation lead 300 includes four first electrodes 310located toward the distal end 302A of the stimulation lead 300 forstimulation of the pudendal nerve, for instance, and four secondelectrodes 320 spaced proximally from the first electrodes 310 forstimulation of the sacral nerve, for instance. In other examples, thestimulation lead 300 includes eight first electrodes 310 located towardthe distal end 302A of the stimulation lead 300 for stimulation of thepudendal nerve, for instance, and four second electrodes 320 spacedproximally from the first electrodes 310 for stimulation of the sacralnerve, for instance. In some examples, the stimulation lead 300 caninclude six first electrodes 310 and six second electrodes 320. Itshould be understood that the examples described herein are merelyexemplary and that other configurations of electrodes 310, 320 arecontemplated herein. In various examples, any electrode configurationcan be used, depending upon the nerve(s) or tissue(s) to be stimulatedand the approach to be used to get to the nerve(s) and/or tissue(s). Insome examples, programming (for instance, within a pulse generator) canbe used to exclude electrodes 310, 320 that do not properly orsufficiently stimulate the target nerve(s) or tissue(s). For instance,an electrode can be excluded if the stimulation from the electrode hastoo much leg recruitment, pain, or another adverse effect.

In some examples, at least one first fixation structure 330 is disposedon the elongate body 302 for at least aiding in anchoring thestimulation lead 300 in place within the patient. In some examples, theat least one fixation structure 330 is disposed on the elongate body 302between the at least one second electrode 320 and the proximal end 302Bof the elongate body 302. In some examples, the at least one firstfixation structure 330 is configured to anchor the stimulation lead 300proximate the sacrum. In some examples, the at least one first fixationstructure 330 is located on the elongate body 302 and spaced a firstdistance X proximally along the elongate body 302 from the at least onefirst electrode 310. In some examples, the first distance X isconfigured to allow the at least one first electrode 310 to bepositioned proximate the first target nerve with the at least one firstfixation structure 330 positioned proximate the sacrum. In someexamples, the first distance X is within the range of 5-10 cm. In someexamples, more than one first fixation structure 330 is contemplated.For instance, in the example shown in FIG. 3, the elongate body 302includes three sets of three first fixation structures 330. In someexamples, the at least one first fixation structure 330 includes a fin.In other examples, the at least one first fixation structure 330includes other fixation structures, such as tines, barbs, coils, or thelike. It is noted that, in various examples, different numbers, sizes,and/or types of fixation structures can be used with the stimulationlead 300, for instance to adjust or tune fixation of the stimulationlead 300 within the patient. In some examples, the at least one firstfixation structure 330 provides main anchoring (major fixation) of thestimulation lead 300.

In some examples, the stimulation lead 300 includes at least one secondfixation structure 340 disposed on the elongate body 302 distally fromthe at least one first fixation structure 330. In some examples, the atleast one second fixation structure 340 is located on the elongate body302 proximate the at least one first electrode 310. In some examples,the at least one second fixation structure 340 is located on theelongate body 302 proximate the distal end 302A of the elongate body302. In the example shown in FIG. 3, the elongate body 302 includes oneset of three second fixation structures 340. In other examples, othernumbers and/or configurations of second fixation structures arecontemplated. The at least one second fixation structure 340 isconfigured to at least partially anchor the stimulation lead 300 inplace within the patient. For instance, in some examples, the at leastone second fixation structure 340 at least partially anchors the distalend 302A of the elongate body 302 within the patient, such as, but notlimited to, at a location proximate the pudendal nerve. In someexamples, the at least one second fixation structure 340 includes a fin.In other examples, the at least one second fixation structure 340includes other fixation structures, such as tines, barbs, coils, or thelike. It is noted that, in various examples, different numbers, sizes,and/or types of fixation structures can be used with the stimulationlead 300, for instance to adjust or tune fixation of the stimulationlead 300 within the patient. In some examples, the at least one secondfixation structure 340 is configured to hold the stimulation lead 300 inplace with respect to the first target nerve, such as, for instance, thepudendal nerve. In some examples, the at least one second fixationstructure 340 is less rigid than the at least one first fixationstructure 330. In some examples, the at least one second fixationstructure 340 can be deployable, for instance, once the at least onesecond fixation structure 340 is past the first and/or second targetnerve to inhibit nerve damage during implantation.

The stimulation lead 300, in some examples, includes one or morecontacts 360 proximate the proximal end 302B of the elongate body 302.The one or more contacts 360, in some examples, are equal in number tothe total number of electrodes 310, 320 on the stimulation lead 300. Insome examples, the stimulation lead 300 includes conductors runningbetween the one or more contacts 360 and the corresponding one or moreelectrodes 310, 320. In the example shown in FIG. 3, the stimulationlead 300 includes eight contacts 360, corresponding to the four firstelectrodes 310 and the four second electrodes 320. In other examples,various other numbers and/or configurations of connectors 360 arecontemplated, depending upon various factors, such as, but not limitedto, the number of electrodes on the stimulation lead, the device towhich the stimulation lead is to be connected, or the like. The one ormore contacts 360, in some examples, are configured for electricallycoupling to one or more connectors, for instance, within a pulsegenerator or other medical device or a lead extension to which thestimulation lead 300 is intended to be connected. In some examples, theone or more contacts 360 are configured to electrically couple the oneor more electrodes 310, 320 to the pulse generator to transmitelectrical stimulation pulses generated by the pulse generator to theappropriate one or more electrodes 310, 320 and, in turn, to theappropriate target nerves and/or target tissue.

Referring now to FIG. 4, a stimulation lead 400 in accordance with someexamples is shown for at least partial implantation within a patient.The stimulation lead 400, in some examples, is substantially similar tothe stimulation lead 100, 300 described herein and/or can be used insubstantially similar ways to those described herein with respect to thestimulation lead 100, 300. The stimulation lead 400, in some examples,includes an elongate body 402 including a distal end 402A and a proximalend 402B. In some examples, the elongate body 402 includes a firstportion 404 and a second portion 406, with the second portion 406 beingcoaxially disposed around the first portion 404. In some examples, withthe stimulation lead 400 in place within the patient, the first portion404 extends distally from a distal end 406A of the second portion 406.In some examples, the first and second portions 404, 406 are coaxialwith the first portion 404 being at least partially disposed within thesecond portion 406. In some examples, such a coaxial lead configurationof the stimulation lead 400 allows the physician or other caregiver tofind one nerve (for instance, the sacral nerve) with the second portion406, and then run the first portion 404 through the second portion 406to find another nerve (for instance, the pudendal nerve).

In some examples, at least one first electrode 410 is disposed proximatethe distal end 402A of the elongate body 402. In some examples, the atleast one first electrode 410 is disposed on the first portion 404 ofthe elongate body 402. In some examples, the stimulation lead 400includes more than one first electrode 410, the first electrodes 410being spaced apart by a spacing distance. In some examples, thestimulation lead 400 can include a spacing distance between the firstelectrodes 410 of about 1-3 mm. In some examples, the first electrodes410 can be about 1-3 mm in length. In some examples, the stimulationlead 400 includes an array of first electrodes 410 proximate the distalend 402A of the elongate body 402. In some examples, the stimulationlead 400 includes a plurality of first electrodes 410. In some examples,the stimulation lead 400 includes four first electrodes 410, as shown inthe example of FIG. 4. In some examples, the at least one firstelectrode 410 is configured to stimulate a first target nerve, such as,but not limited to the pudendal nerve.

In some examples, at least one second electrode 420 is disposed betweenthe at least one first electrode 410 and the proximal end 402B of theelongate body 402. In some examples, the at least one second electrode420 is disposed on the second portion 406 of the elongate body 402. Insome examples, with the at least one first electrode 410 disposed on thefirst portion 404 and the at least second electrode 420 disposed on thesecond portion 406, an electrode distance Y between the at least onefirst electrode 410 and the at least one second electrode 420 isadjustable with movement of the second portion 406 of the elongate body402 with respect to the first portion 404 of the elongate body 402.

In some examples, the stimulation lead 400 includes more than one secondelectrode 420, the second electrodes 420 being spaced apart by a spacingdistance. In some examples, the second electrodes 420 can be about 1-3mm in length. In some examples, the stimulation lead 400 can include aspacing distance between the second electrodes 420 of about 1-3 mm. Insome examples, the stimulation lead 400 includes an array of secondelectrodes 420 disposed between the at least one first electrode 410 andthe proximal end 402B of the elongate body 402. In some examples, thestimulation lead 400 includes a plurality of second electrodes 420. Insome examples, the stimulation lead 400 includes four second electrodes420, as shown in the example of FIG. 4. In some examples, the at leastone second electrode 420 is configured to stimulate a second targetnerve, such as, but not limited to the sacral nerve.

In some examples, the stimulation lead 400 includes one to twelveelectrodes 410, 420 in various configurations. For instance, in someexamples, the stimulation lead 400 includes four first electrodes 410located toward the distal end 402A of the stimulation lead 400 forstimulation of the pudendal nerve, for instance, and four secondelectrodes 420 spaced proximally from the first electrodes 410 forstimulation of the sacral nerve, for instance. In other examples, thestimulation lead 400 includes eight first electrodes 410 located towardthe distal end 402A of the stimulation lead 400 for stimulation of thepudendal nerve, for instance, and four second electrodes 420 spacedproximally from the first electrodes 410 for stimulation of the sacralnerve, for instance. In some examples, the stimulation lead 400 caninclude six first electrodes 410 and six second electrodes 420. Itshould be understood that the examples described herein are merelyexemplary and that other configurations of electrodes 410, 420 arecontemplated herein. In various examples, any electrode configurationcan be used, depending upon the nerve(s) or tissue(s) to be stimulatedand the approach to be used to get to the nerve(s) and/or tissue(s). Insome examples, programming (for instance, within a pulse generator) canbe used to exclude electrodes 410, 420 that do not properly orsufficiently stimulate the target nerve(s) or tissue(s). For instance,an electrode can be excluded if the stimulation from the electrode hastoo much leg recruitment, pain, or another adverse effect.

Moreover, with the first portion 404 and the second portion 406 of theelongate body 402 being movable with respect to one another and theelectrode distance Y being variable, a physician or other caregiverimplanting the stimulation lead 400 is more flexible with where heplaces the at least one first electrode 410 with respect to the firsttarget nerve or tissue and where he places the at least one secondelectrode 420 with respect to the second target nerve or tissue. Thatis, the physician or other caregiver is not confined to a givenelectrode distance between first and second electrodes, such as, forinstance, on a single elongate body. Instead, the physician or othercaregiver, in some examples, can place the at least one first electrode410 in a desired location with respect to the first target nerve ortissue and the at least one second electrode 420 in a desired locationwith respect to the second target nerve or tissue. In some examples,once the second portion 406 of the elongate body 402 is in place withrespect to the first portion 404 of the elongate body 402, the firstportion 404 and the second portion 406 can be fixed with respect to oneanother. In some examples, an attachment device 450 can be used to fixthe first portion 404 with respect to the second portion 406. In someexamples, the attachment device 450 can include a suture sleeve oranchor that, with tightening of a suture, compresses the second portion406 against the first portion 404, thereby compressively engaging thefirst portion 404 with respect to the second portion 406. In otherexamples, the attachment device 450 can include a crimp sleeve that,with squeezing of the crimp sleeve, compresses the second portion 406against the first portion 404, thereby compressively engaging the firstportion 404 with respect to the second portion 406. In still otherexamples, the first portion 404 can be threadedly engaged with thesecond portion 406 for threaded advancement of the first portion 404with respect to the second portion 406. It is noted that the exampleattachment devices 450 described above are just but a few of thepossible attachment devices 450 and that, in various examples, differentattachment devices 450 can be used with the stimulation lead 400 to fixthe first portion 404 with respect to the second portion 406.

In some examples, the first portion 404 can include no electrodes or caninclude electrodes that are excluded if the stimulation lead 400 isintended only for stimulation of the first target nerve, such as, forinstance, the pudendal nerve. For instance, in some examples, ifapproaching the pudendal nerve along the S2 nerve, the first portion 404can be used to follow along the S2 nerve and establish the trajectory ofthe stimulation lead 400 in order to pass the second portion 406 throughthe first portion 404 to then follow down to the pudendal nerve. Sincestimulation of the S2 nerve, in some examples, is not desirable, thefirst portion 404 can be devoid of electrodes or the electrodes of thefirst portion 404 can be excluded or turned off so as not to stimulatethe S2 nerve.

In some examples, at least one first fixation structure 430 is disposedon the elongate body 402 for at least aiding in anchoring thestimulation lead 400 in place within the patient. In some examples, theat least one fixation structure 430 is disposed on the elongate body 402between the at least one second electrode 420 and the proximal end 402Bof the elongate body 402. In some examples, the at least one firstfixation structure 430 is configured to anchor the stimulation lead 400proximate the sacrum. In some examples, the at least one first fixationstructure 430 is disposed on the second portion 406 of the elongate body402. In some examples, with the at least one first fixation structure430 located on the second portion 406 of the elongate body 402, a firstdistance measured proximally along the elongate body 402 from the atleast one first electrode 410, like the electrode distance Y, isvariable and selectively adjustable by the physician or other caregiver.In some examples, the first distance can be set (by adjusting the firstportion 404 with respect to the second portion 406) to allow the atleast one first electrode 410 to be positioned proximate the firsttarget nerve with the at least one first fixation structure 430positioned proximate the sacrum. In some examples, the first distancecan be set to within the range of 5-10 cm. In some examples, more thanone first fixation structure 430 is contemplated. For instance, in theexample shown in FIG. 4, the elongate body 402 includes three sets ofthree first fixation structures 430. In some examples, the at least onefirst fixation structure 430 includes a fin. In other examples, the atleast one first fixation structure 430 includes other fixationstructures, such as tines, barbs, coils, or the like. It is noted that,in various examples, different numbers, sizes, and/or types of fixationstructures can be used with the stimulation lead 400, for instance toadjust or tune fixation of the stimulation lead 400 within the patient.In some examples, the at least one first fixation structure 430 providesmain anchoring (major fixation) of the stimulation lead 400.

In some examples, the stimulation lead 400 includes at least one secondfixation structure 440 disposed on the elongate body 402 distally fromthe at least one first fixation structure 430. In some examples, the atleast one second fixation structure 440 is located on the elongate body402 proximate the at least one first electrode 410. In some examples,the at least one second fixation structure 440 is located on theelongate body 402 proximate the distal end 402A of the elongate body402. In some examples, the at least one second fixation structure 440 islocated on the first portion 404 of the elongate body 402. In theexample shown in FIG. 4, the elongate body 402 includes one set of threesecond fixation structures 440. In other examples, other numbers and/orconfigurations of second fixation structures are contemplated. The atleast one second fixation structure 440 is configured to at leastpartially anchor the stimulation lead 400 in place within the patient.For instance, in some examples, the at least one second fixationstructure 440 at least partially anchors the distal end 402A of theelongate body 402 within the patient, such as, but not limited to, at alocation proximate the pudendal nerve. In some examples, the at leastone second fixation structure 440 includes a fin. In other examples, theat least one second fixation structure 340 includes other fixationstructures, such as tines, barbs, coils, or the like. It is noted that,in various examples, different numbers, sizes, and/or types of fixationstructures can be used with the stimulation lead 400, for instance toadjust or tune fixation of the stimulation lead 400 within the patientIn other examples, the stimulation lead 400 includes no second fixationstructures. In some examples, the at least one second fixation structure440 is configured to hold the stimulation lead 400 in place with respectto the first target nerve, such as, for instance, the pudendal nerve. Insome examples, the at least one second fixation structure 440 is lessrigid than the at least one first fixation structure 430. In someexamples, the at least one second fixation structure 440 can bedeployable, for instance, once the at least one second fixationstructure 440 is past the first and/or second target nerve to inhibitnerve damage during implantation.

The stimulation lead 400, in some examples, includes one or more firstcontacts 460 proximate the proximal end 402B of the elongate body 402.In some examples, the one or more first contacts 460 are disposed on aproximal portion of the first portion 404 of the elongate body 402 withthe first portion 404 extending proximally from a proximal end 406B ofthe second portion 406. In some examples, the stimulation lead 400includes one or more second contacts 470 proximate the proximal end 4029of the elongate body 402. In some examples, the one or more secondcontacts 470 are disposed on the second portion 406 of the elongate body402 proximate the proximal end 4069 of the second portion 406. The oneor more first and second contacts 460, 470, in some examples, are equalin number to the total number of electrodes 410, 320 on the stimulationlead 400. In some examples, the stimulation lead 400 includes conductorsrunning between the one or more first contacts 460 and the correspondingone or more first electrodes 410 and running between the one or moresecond contacts 470 and the corresponding one or more second electrodes420. In the example shown in FIG. 4, the stimulation lead 400 includesfour first contacts 460 and four second contacts 470, corresponding tothe four first electrodes 410 and the four second electrodes 420,respectively. In other examples, various other numbers and/orconfigurations of first and second connectors 460, 470 are contemplated,depending upon various factors, such as, but not limited to, the numberof electrodes on the stimulation lead, the device to which thestimulation lead is to be connected, or the like. The one or more firstand second contacts 460, 470, in some examples, are configured forelectrically coupling to one or more connectors, for instance, within apulse generator or other medical device or a lead extension to which thestimulation lead 400 is intended to be connected. In some examples, theone or more first and second contacts 460, 470 are configured toelectrically couple the one or more electrodes 410, 420 to the pulsegenerator to transmit electrical stimulation pulses generated by thepulse generator to the appropriate one or more electrodes 410, 420 and,in turn, to the appropriate target nerves and/or target tissue.

Referring now to FIG. 5, a stimulation lead 500 in accordance with someexamples is shown for at least partial implantation within a patient.The stimulation lead 500, in some examples, is substantially similar tothe stimulation lead 100, 300, 400 described herein and/or can be usedin substantially similar ways to those described herein with respect tothe stimulation lead 100, 300, 400. The stimulation lead 500, in someexamples, includes an elongate body 502 including a distal end 502A anda proximal end.

In some examples, at least one first electrode 510 is disposed proximatethe distal end 502A of the elongate body 502. In some examples, thestimulation lead 500 includes more than one first electrode 510, thefirst electrodes 510 being spaced apart by a spacing distance. In someexamples, the stimulation lead 500 can include a spacing distancebetween the first electrodes 510 of about 1-3 mm. In some examples, thefirst electrodes 510 can be about 1-3 mm in length. In some examples,the stimulation lead 500 includes an array of first electrodes 510proximate the distal end 502A of the elongate body 502. In someexamples, the stimulation lead 500 includes a plurality of firstelectrodes 510. In some examples, the stimulation lead 500 includes fourfirst electrodes 510, as shown in the example of FIG. 5. In someexamples, the at least one first electrode 510 is configured tostimulate a first target nerve, such as, but not limited to the pudendalnerve. In various examples, any electrode configuration can be used,depending upon the nerve(s) or tissue(s) to be stimulated and theapproach to be used to get to the nerve(s) and/or tissue(s).

In some examples, at least one second electrode 520 is disposed betweenthe at least one first electrode 510 and the proximal end 502B of theelongate body 502. In some examples, the stimulation lead 500 includesmore than one second electrode 520, the second electrodes 520 beingspaced apart by a spacing distance. In some examples, the secondelectrodes 520 can be about 1-3 mm in length. In some examples, thestimulation lead 500 can include a spacing distance between the secondelectrodes 520 of about 1-3 mm. In some examples, the stimulation lead500 includes an array of second electrodes 520 disposed between the atleast one first electrode 510 and the proximal end 502B of the elongatebody 502. In some examples, the stimulation lead 500 includes aplurality of second electrodes 520. In some examples, the stimulationlead 500 includes four second electrodes 520, as shown in the example ofFIG. 5. In some examples, the at least one second electrode 520 isconfigured to stimulate a second target nerve, such as, but not limitedto the sac..-Tal nerve. In various examples, any electrode configurationcan be used, depending upon the nerve(s) or tissue(s) to be stimulatedand the approach to be used to get to the nerve(s) and/or tissue(s).

In some examples, at least one first fixation structure 530 is disposedon the elongate body 502 for at least aiding in anchoring thestimulation lead 500 in place within the patient. In some examples, theat least one fixation structure 530 is disposed on the elongate body 502between the at least one second electrode 520 and the proximal end ofthe elongate body 502. In some examples, the at least one first fixationstructure 530 is configured to anchor the stimulation lead 500 proximatethe sacrum. In some examples, the at least one first fixation structure530 is located on the elongate body 502 and spaced a first distanceproximally along the elongate body 502 from the at least one firstelectrode 510. In some examples, the first distance is configured toallow the at least one first electrode 510 to be positioned proximatethe first target nerve with the at least one first fixation structure530 positioned proximate the sacrum. In some examples, the firstdistance is within the range of 5-10 cm. In some examples, more than onefirst fixation structure 530 is contemplated. For instance, in theexample shown in FIG. 5, the elongate body 502 includes three sets ofthree first fixation structures 530. In some examples, the at least onefirst fixation structure 530 includes a fin. In other examples, the atleast one first fixation structure 530 includes other fixationstructures, such as tines, barbs, coils, or the like. It is noted that,in various examples, different numbers, sizes, and/or types of fixationstructures can be used with the stimulation lead 500, for instance toadjust or tune fixation of the stimulation lead 500 within the patient.In some examples, the at least one first fixation structure 530 providesmain anchoring (major fixation) of the stimulation lead 500.

In some examples, the at least one first fixation structure 530 of thestimulation lead 500 includes one or more deployable fixation structures530 to allow the physician or other caregiver to make sure thestimulation lead 500 is in the proper location before deploying the oneor more deployable fixation structures 530. For instance, in someexamples, such a configuration allows the physician or other caregiverto make sure that the chosen sacral nerve (S2, S3, or S4 nerve, forinstance) is the correct access for the pudendal nerve before deployingthe at least one first fixation structure 530.

In some examples, a sheath 590 is removably disposed around at least theat least one first fixation structure 530 for selectively deploying theat least one first fixation structure 530. In such examples, the atleast one first fixation structure 530 includes a delivery configurationwith the sheath 590 disposed around the at least one first fixationstructure 530 to constrain the at least one first fixation structure 530against the elongate body 502 and/or inhibit the at least one firstfixation structure 530 from engaging tissue of the patient and at leastpartially anchoring the stimulation lead 500 in place within thepatient. Further, in such examples, the at least one first fixationstructure 530 includes a deployed configuration with the sheath 590removed from around the at least one first fixation structure 530 toallow the at least one first fixation structure 530 to extend outwardlyfrom the elongate body 502. In some examples, the sheath 590 is removedfrom around the at least one first fixation structure 530 by pulling thesheath 590 in direction A with respect to the stimulation lead 500 touncover the at least one first fixation structure 530. The at least onefirst fixation structure 530, in some examples, is biased to thedeployed configuration, so, with the sheath 590 pulled back anduncovering the at least one first fixation structure 530, the at leastone first fixation structure 530 is free to move to the deployedconfiguration to contact tissue of the patient and at least partiallyanchor the stimulation lead 500 in place within the patient.

In some examples, a sheath, similar to that described herein withrespect to the stimulation lead 500, can be similarly used withstimulation leads 100, 300, 400 described herein. For instance,referring again to FIG. 4, with respect to the stimulation lead 400, insome examples, the first portion 404 allows the physician to determinethe proper trajectory of the stimulation lead 400 before deploying theat least one first fixation structure 430. In some examples, thephysician or other caregiver can map as the stimulation lead 400 isimplanting (for instance, using test stimulations and measuringresponses to approach the target nerve). Then, when the stimulation lead400 is in the proper position with respect to the second target nerve,such as, for instance, the sacral nerve. Once in place, the at least onefirst fixation structure 430 can be deployed (for instance, by removinga sheath similar to the sheath 590 from around the first portion 404),and the second portion 406 can be run through the first portion 404 toextend beyond the first portion 404 to find the first target nerve, suchas, for instance, the pudendal nerve. Once the second portion 406 is inplace, in some examples, the attachment device 450 can be secured,affixed, compressed, or otherwise actuated to engage the second portion406 to the first portion 404 to inhibit the first and second portions404, 406 from moving with respect to one another. In some examples, suchas examples in which the stimulation lead 400 includes at least onesecond fixation structure 440, another sheath (for instance, similar tothe sheath 590) can be used to cover and retain the at least one secondfixation structure 440 in a delivery configuration until which pointthat the physician or other caregiver is ready to anchor the firstportion 404. At this point, the other sheath can be removed fromcovering the at least one second fixation structure 440, allowing the atleast one second fixation structure 440 to move to the deployedconfiguration to at least partially anchor the first portion 404 withrespect to the patient.

The present inventors have recognized various advantages of the subjectmatter described herein. For instance, in some examples, theapparatuses, systems, and methods described herein can be used tostimulate one or more nerves or other tissue. The present inventors haverecognized, among other things, that the subject matter can be used withan implantable stimulation system. The inventors have further recognizedthat, in some examples, the pudendal nerve can be accessed via thesacral nerve and that a single stimulation device can be used tostimulate one or both of the pudendal and the sacral nerves. Whilevarious advantages of the example apparatuses, systems, and methods arelisted herein, this list is not considered to be complete, as furtheradvantages may become apparent from the description and figurespresented herein.

Although the subject matter of the present patent application has beendescribed with reference to various examples, workers skilled in the artwill recognize that changes can be made in form and detail withoutdeparting from the scope of the subject matter recited in the belowclaims.

The above Detailed Description includes references to the accompanyingdrawings, which form a part of the Detailed Description. The drawingsshow, by way of illustration, specific examples in which the presentapparatuses and methods can be practiced. These embodiments are alsoreferred to herein as “examples.”

The above Detailed Description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreelements thereof) can be used in combination with each other. Otherembodiments can be used, such as by one of ordinary skill in the artupon reviewing the above description. Also, various features or elementscan be grouped together to streamline the disclosure. This should not beinterpreted as intending that an unclaimed disclosed feature isessential to any claim. Rather, inventive subject matter can lie in lessthan all features of a particular disclosed embodiment. Thus, thefollowing claims are hereby incorporated into the Detailed Description,with each claim standing on its own as a separate embodiment. The scopeof the invention should be determined with reference to the appendedclaims, along with the full scope of equivalents to which such claimsare entitled.

In this document, the terms “a” or “an” are used to include one or morethan one, independent of any other instances or usages of “at least one”or “one or more.” In this document, the term “or” is used to refer to anonexclusive or, such that “A or B” includes “A but not B,” “B but notA,” and “A and B,” unless otherwise indicated. In this document, theterms “about” and “approximately” or similar are used to refer to anamount that is nearly, almost, or in the vicinity of being equal to astated amount.

In the appended claims, the terms “including” and “in which” are used asthe plain-English equivalents of the respective terms “comprising” and“wherein.” Also, in the following claims, the terms “including” and“comprising” are open-ended, that is, an apparatus or method thatincludes elements in addition to those listed after such a term in aclaim are still deemed to fall within the scope of that claim. Moreover,in the following claims, the terms “first,” “second,” and “third,” etc.are used merely as labels, and are not intended to impose numericalrequirements on their objects.

The Abstract is provided to allow the reader to quickly ascertain thenature of the technical disclosure. It is submitted with theunderstanding that it will not be used to interpret or limit the scopeor meaning of the claims.

1. A stimulation lead comprising: an elongate body including a distalend and a proximal end, wherein the elongate body includes a firstportion and a second portion, wherein the second portion is coaxiallydisposed around the first portion; at least one first electrode disposedon the first portion of the elongate body proximate the distal end ofthe elongate body, the at least one first electrode configured tostimulate a first target nerve; and at least one second electrodedisposed on the second portion of the elongate body between the at leastone first electrode and the proximal end of the elongate body, the atleast one second electrode configured to stimulate a second targetnerve, wherein an electrode distance between the at least one firstelectrode and the at least one second electrode is adjustable withmovement of the second portion of the elongate body with respect to thefirst portion of the elongate body.
 2. The stimulation lead of claim 1,wherein the at least one first electrode includes a plurality of firstelectrodes, and the at least one second electrode includes a pluralityof second electrodes.
 3. The stimulation lead of claim 1, comprising atleast one first fixation structure disposed between the at least onesecond electrode and the proximal end of the elongate body, the at leastone first fixation structure being configured to anchor the stimulationlead proximate a sacrum, wherein the at least one first fixationstructure is located on the elongate body and spaced a first distanceproximally along the elongate body from the at least one firstelectrode.
 4. The stimulation lead of claim 3, comprising at least onesecond fixation structure disposed on the elongate body distally fromthe at least one first fixation structure.
 5. The stimulation lead ofclaim 4, wherein the at least one second fixation structure is locatedon the elongate body proximate the at least one first electrode.
 6. Tuestimulation lead of claim 3, comprising a sheath removably disposedaround at least the at least one first fixation structure, wherein theat least one first fixation structure includes: a delivery configurationwith the sheath disposed around the at least one first fixationstructure to constrain the at least one first fixation structure; and adeployed configuration with the sheath removed from around the at leastone first fixation structure to allow the at least one first fixationstructure to extend outwardly from the elongate body.
 7. The stimulationlead of claim 3, wherein the at least one first fixation structureincludes at least one fin.
 8. A stimulation lead comprising: an elongatebody including a distal end and a proximal end, wherein the elongatebody includes a first portion and a second portion, wherein the secondportion is coaxially disposed around the first portion; at least twofirst electrodes disposed on the first portion of the elongate bodyproximate the distal end of the elongate body, the at least two firstelectrodes configured to stimulate a first target nerve; and at leasttwo second electrodes disposed on the second portion of the elongatebody between the at least two first electrodes and the proximal end ofthe elongate body, the at least two second electrodes configured tostimulate a second target nerve.
 9. The stimulation lead of claim 8,wherein an electrode distance between the at least two first electrodesand the at least two second electrodes is adjustable with movement ofthe second portion of the elongate body with respect to the firstportion of the elongate body.
 10. The stimulation lead of claim 8,further comprising: at least one first fixation structure disposedbetween the at least two second electrodes and the proximal end of theelongate body, the at least one first fixation structure beingconfigured to anchor the stimulation lead proximate a sacrum.
 11. Thestimulation lead of claim 10, wherein the at least one first fixationstructure is located on the elongate body and spaced a first distanceproximally along the elongate body from the at least two firstelectrodes.
 12. The stimulation lead of claim 10, comprising: at leastone second fixation structure disposed on the elongate body distallyfrom the at least one first fixation structure, wherein the at least onesecond fixation structure is located on the elongate body proximate theat least two first electrodes.
 13. The stimulation lead of claim 10,comprising: a sheath removably disposed around at least the at least onefirst fixation structure.
 14. The stimulation lead of claim 13, whereinthe at least one first fixation structure includes: a deliveryconfiguration with the sheath disposed around the at least one firstfixation structure to constrain the at least one first fixationstructure.
 15. The stimulation lead of claim 14, wherein the at leastone first fixation structure further includes: a deployed configurationwith the sheath removed from around the at least one first fixationstructure to allow the at least one first fixation structure to extendoutwardly from the elongate body.
 16. A stimulation lead comprising: anelongate body including a distal end and a proximal end, wherein theelongate body includes a first portion and a second portion, wherein thesecond portion is coaxially disposed around the first portion; a firstelectrode disposed on the first portion of the elongate body, the firstelectrode being configured to stimulate a pudendal nerve; and a secondelectrode disposed on the second portion of the elongate body, thesecond electrode being configured to stimulate a sacral nerve.
 17. Thestimulation lead of claim 16, wherein an electrode distance between thefirst electrode and the second electrode is adjustable with a movementof the second portion of the elongate body with respect to the firstportion of the elongate body.
 18. The stimulation lead of claim 16,comprising: a first fixation structure disposed between the secondelectrode and the proximal end of the elongate body, the first fixationstructure being configured to anchor the stimulation lead proximate asacrum, wherein the first fixation structure is located on the elongatebody and spaced a first distance proximally along the elongate body fromthe first electrode; and a second fixation structure disposed on theelongate body distally from the first fixation structure, wherein thesecond fixation structure is located on the elongate body proximate thefirst electrode.
 19. The stimulation lead of claim 18, wherein the firstfixation structure and the second fixation structure each comprise fins.20. The stimulation lead of claim 18, further comprising: a sheathremovably disposed around the first fixation structure or the secondfixation structure, wherein the first fixation structure or the secondfixation structure includes: a delivery configuration with the sheathdisposed around the first fixation structure to constrain the firstfixation structure; or a deployed configuration with the sheath removedfrom around the first fixation structure to allow the first fixationstructure to extend outwardly from the elongate body.